Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Resound Corp. — Predicate Candidate Screening

41 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

50 daysmedian FDA review time

127 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days
K984547	DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HE	Resound Corp.	1999-03-19	87
K974081	RESOUND STEALTH CIC	Resound Corp.	1997-12-12	44
K974257	RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMME	Resound Corp.	1997-12-12	29
K971605	RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION	Resound Corp.	1997-07-03	63
K970215	AUDALLION II HEARING SYSTEM	Resound Corp.	1997-03-31	69
K964557	RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION	Resound Corp.	1996-11-27	14
K964115	RESOUND CC4 PERSONAL HEARING SYSTEM	Resound Corp.	1996-11-04	20
K960684	HEARING AID - AIR CONDUCTION	Resound Corp.	1996-04-10	50
K960680	RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS ED	Resound Corp.	1996-04-10	50
K960052	RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241	Resound Corp.	1996-03-12	68
K960229	RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM	Resound Corp.	1996-03-07	50
K955867	RESOUND PERSONAL HEARING SYSTEM BT247	Resound Corp.	1996-02-02	36
K955574	RESOUND PERSONAL HEARING SYSTEM BTP W/DAI	Resound Corp.	1995-12-22	15
K953266	RESOUND PERSONAL HEARING SYSTEM BT250 MZ W/REMOTE CONTROL OP	Resound Corp.	1995-07-26	13
K952228	SONAR CIC COMPLETELY IN-THE-CANAL HEARING DEVICE	Resound Corp.	1995-06-05	25
K951068	RESOUND ED4-M MINI-CANAL PERSONAL HEARING SYSTEM W/REMOTE CO	Resound Corp.	1995-05-12	65
K951067	RESOUND ED4-C CANAL PERSONAL HEARING SYSTEM W/REMOTE CONTROL	Resound Corp.	1995-05-12	65
K951378	RESOUND PERSONAL HEARING SYSTEM MODELS BTP2 & BTP2/S W/REMOT	Resound Corp.	1995-04-27	31
K951379	RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMON	Resound Corp.	1995-04-27	31
K951376	RESOUND PERSONAL HEARING SYSTEM BT2/S SERIES W/REMOTE CONTRO	Resound Corp.	1995-04-14	18
K951377	RESOUND PERSONAL HEARING SYSTEM BTP/S-A W/REMOTE CONTROL OPT	Resound Corp.	1995-04-14	18
K951375	RESOUND PERSONAL HEARING SYSTEM ED3/S-E	Resound Corp.	1995-04-14	18
K951374	RESOUND PERSONAL HEARING SYSTEM BT2/S-E	Resound Corp.	1995-04-14	18
K945750	RESOUND(R) RESOURCE(TM)	Resound Corp.	1995-03-07	104
K950319	RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE	Resound Corp.	1995-02-08	13
K934917	RESOUND PERSONAL HEARING SYSTEMS MODIFICATION	Resound Corp.	1995-01-19	463
K944041	PERSONAL HEARING SYSTEM	Resound Corp.	1994-12-27	131
K944043	BTP-A HEARING SYSTEM	Resound Corp.	1994-12-23	127
K943788	RESOUND PERSONAL HEARING SYSTEM	Resound Corp.	1994-09-21	49
K931372	RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM	Resound Corp.	1993-11-03	231
K931942	RESOUND PERSONAL HEARING SYSTEM BT-P W/PHS BT-P	Resound Corp.	1993-07-20	92
K922570	RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1	Resound Corp.	1992-08-06	66
K912669	RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM	Resound Corp.	1991-09-16	90
K912665	SYSTEM BT W/REMOTE CONTROL OPTION HEARING AID	Resound Corp.	1991-07-24	36
K896463	RESOUND CUSTOM IN-THE CANAL HEARING AID MODEL CA1	Resound Corp.	1990-02-08	87
K894019	RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE	Resound Corp.	1989-09-21	107
K893927	RESOUND CUSTOM IN-THE CANAL HEARING AID PHS-3	Resound Corp.	1989-08-04	65
K892935	RESOUND IMPRESSION MATERIAL	Resound Corp.	1989-07-14	84
K891011	RESOUND ITC HEARING ENHANCEMENT SYS HES2, W/REMOTE	Resound Corp.	1989-03-29	29
K884044	AUDIOMETER DIGITAL HEARING SYSTEM	Resound Corp.	1989-02-22	149
K884871	RESOUND HES, DIGITALLY PROGR., ITE HEARING AID	Resound Corp.	1989-02-22	93

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda